Trial Outcomes & Findings for Gemcitabine, Oxaliplatin, Tarceva &/or Cisplatin in HCC & Biliary Tree Cancers (NCT NCT00832637)
NCT ID: NCT00832637
Last Updated: 2018-06-29
Results Overview
Rate of tumor control is defined as the percentage of patients achieving a complete response (CR) + partial response (PR) + stable disease (SD) at 24 weeks following treatment. Response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
24 weeks
Results posted on
2018-06-29
Participant Flow
Participant milestones
| Measure |
Gemcitabine, Cisplatin, Erlotinib
Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.
Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
Erlotinib: 100 mg orally daily.
Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.
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|---|---|
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Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine, Oxaliplatin, Tarceva &/or Cisplatin in HCC & Biliary Tree Cancers
Baseline characteristics by cohort
| Measure |
Gemcitabine, Cisplatin, Erlotinib
n=33 Participants
Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.
Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
Erlotinib: 100 mg orally daily.
Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.
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|---|---|
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Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
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8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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25 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 24 weeksRate of tumor control is defined as the percentage of patients achieving a complete response (CR) + partial response (PR) + stable disease (SD) at 24 weeks following treatment. Response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Gemcitabine, Cisplatin, Erlotinib
n=33 Participants
Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.
Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
Erlotinib: 100 mg orally daily.
Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.
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|---|---|
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Tumor Control Rate
Complete response (CR)
|
0 percentage of evaluable participants
|
|
Tumor Control Rate
Partial response (PR)
|
7.1 percentage of evaluable participants
|
|
Tumor Control Rate
Stable disease (SD)
|
53.6 percentage of evaluable participants
|
|
Tumor Control Rate
CR + PR + SD
|
60.7 percentage of evaluable participants
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SECONDARY outcome
Timeframe: 24 weeksOverall response rate is defined as the percentage of patients achieving a complete response (CR) + partial response (PR) at 24 weeks following treatment. Response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Gemcitabine, Cisplatin, Erlotinib
n=28 Participants
Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.
Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
Erlotinib: 100 mg orally daily.
Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.
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|---|---|
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Overall Response Rate
Complete response (CR)
|
0 percentage of evaluable participants
|
|
Overall Response Rate
Partial response (PR)
|
7.1 percentage of evaluable participants
|
|
Overall Response Rate
CR + PR
|
7.1 percentage of evaluable participants
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SECONDARY outcome
Timeframe: 2 yearsThe time from treatment initiation to disease progression. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Gemcitabine, Cisplatin, Erlotinib
n=33 Participants
Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.
Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
Erlotinib: 100 mg orally daily.
Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.
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|---|---|
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Time to Tumor Progression (TTP)
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22 weeks
Interval 18.0 to 78.0
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SECONDARY outcome
Timeframe: 2 yearsSurvival is defined as the time from treatment initiation to death by any cause
Outcome measures
| Measure |
Gemcitabine, Cisplatin, Erlotinib
n=33 Participants
Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.
Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
Erlotinib: 100 mg orally daily.
Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.
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|---|---|
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Median Survival Time (MST)
|
28 weeks
Interval 21.0 to 53.0
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SECONDARY outcome
Timeframe: Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition. An average of 24 weeksToxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Frequency and severity of adverse events will be tabulated using counts of frequently occurring, serious and severe events of interest (i.e. Grade 3 and Grade 4 adverse events).
Outcome measures
| Measure |
Gemcitabine, Cisplatin, Erlotinib
n=33 Participants
Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.
Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
Erlotinib: 100 mg orally daily.
Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.
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|---|---|
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Toxicity
Anemia
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2 participants
|
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Toxicity
Neutropenia
|
7 participants
|
|
Toxicity
Neutropenic Fever
|
2 participants
|
|
Toxicity
Thrombocytopenia
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6 participants
|
|
Toxicity
Diarrhea
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4 participants
|
|
Toxicity
Abdominal Pain
|
2 participants
|
|
Toxicity
Renal Failure
|
1 participants
|
|
Toxicity
Dermatitis (acneiform)
|
3 participants
|
|
Toxicity
Peripheral neuropathy
|
1 participants
|
|
Toxicity
Metabolic syndrome
|
2 participants
|
|
Toxicity
Cerebral hemorrhage
|
1 participants
|
Adverse Events
Gemcitabine, Cisplatin, Erlotinib
Serious events: 17 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine, Cisplatin, Erlotinib
n=33 participants at risk
Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.
Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
Erlotinib: 100 mg orally daily.
Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.
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|---|---|
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Immune system disorders
Hypersensitivity reaction
|
3.0%
1/33 • Number of events 1 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Blood and lymphatic system disorders
Hemolysis (Red blood cell destruction)
|
3.0%
1/33 • Number of events 1 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
General disorders
Fatigue
|
3.0%
1/33 • Number of events 1 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
General disorders
Fever
|
6.1%
2/33 • Number of events 3 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Gastrointestinal disorders
Anorexia (Loss of appetite)
|
3.0%
1/33 • Number of events 1 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Gastrointestinal disorders
Ascites
|
6.1%
2/33 • Number of events 2 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
1/33 • Number of events 1 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Gastrointestinal disorders
Gastritis (Stomach lining inflammation)
|
3.0%
1/33 • Number of events 1 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
3.0%
1/33 • Number of events 1 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Infections and infestations
Device related infection
|
3.0%
1/33 • Number of events 1 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Infections and infestations
Febrile neutropenia
|
3.0%
1/33 • Number of events 1 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Infections and infestations
Pneumonia
|
6.1%
2/33 • Number of events 2 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
1/33 • Number of events 1 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Investigations
Hypokalemia (Low potassium level in blood)
|
3.0%
1/33 • Number of events 1 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Nervous system disorders
Extrapyramidal disorder
|
3.0%
1/33 • Number of events 1 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
General disorders
Abdominal pain
|
6.1%
2/33 • Number of events 2 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
General disorders
Chest pain
|
3.0%
1/33 • Number of events 1 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Renal and urinary disorders
Renal failure
|
3.0%
1/33 • Number of events 1 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
General disorders
Death
|
12.1%
4/33 • Number of events 4 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
Other adverse events
| Measure |
Gemcitabine, Cisplatin, Erlotinib
n=33 participants at risk
Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.
Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
Erlotinib: 100 mg orally daily.
Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.
|
|---|---|
|
General disorders
Rhinitis (Runny nose)
|
15.2%
5/33 • Number of events 12 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
15.2%
5/33 • Number of events 12 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Blood and lymphatic system disorders
Hemolysis (Red blood cell destruction)
|
21.2%
7/33 • Number of events 7 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Blood and lymphatic system disorders
Leukocytes decreased
|
21.2%
7/33 • Number of events 10 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Blood and lymphatic system disorders
Neutrophils decreased
|
21.2%
7/33 • Number of events 18 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
42.4%
14/33 • Number of events 44 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Cardiac disorders
Atrial tachycardia
|
6.1%
2/33 • Number of events 2 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
General disorders
Fatigue
|
66.7%
22/33 • Number of events 27 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
General disorders
Fever
|
24.2%
8/33 • Number of events 9 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
General disorders
Weight Loss
|
15.2%
5/33 • Number of events 6 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Alopecia (Hair loss)
|
6.1%
2/33 • Number of events 3 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Hand and foot syndrome
|
6.1%
2/33 • Number of events 3 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.2%
6/33 • Number of events 7 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Acne
|
27.3%
9/33 • Number of events 12 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Desquamating rash
|
27.3%
9/33 • Number of events 9 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Gastrointestinal disorders
Abdominal distention
|
9.1%
3/33 • Number of events 3 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Gastrointestinal disorders
Anorexia (Loss of appetite)
|
30.3%
10/33 • Number of events 10 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Gastrointestinal disorders
Ascites (Accumulation of fluid in the abdomen)
|
12.1%
4/33 • Number of events 4 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Gastrointestinal disorders
Constipation
|
24.2%
8/33 • Number of events 9 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Gastrointestinal disorders
Dehydration
|
18.2%
6/33 • Number of events 7 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
54.5%
18/33 • Number of events 22 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Gastrointestinal disorders
Gastritis (Stomach lining inflammation)
|
6.1%
2/33 • Number of events 2 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Gastrointestinal disorders
Nausea
|
48.5%
16/33 • Number of events 19 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
11/33 • Number of events 14 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
General disorders
Epistaxis (Nosebleed)
|
9.1%
3/33 • Number of events 3 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Infections and infestations
Febrile neutropenia
|
9.1%
3/33 • Number of events 3 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Infections and infestations
Urinary Tract Infection
|
6.1%
2/33 • Number of events 2 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
General disorders
Edema: limbs
|
9.1%
3/33 • Number of events 5 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
General disorders
Edema: trunk/genital
|
6.1%
2/33 • Number of events 3 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Investigations
Alkaline phosphatase increased
|
6.1%
2/33 • Number of events 3 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
6.1%
2/33 • Number of events 2 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Investigations
Hyperbilirubinemia (High level of bilirubin)
|
18.2%
6/33 • Number of events 10 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Investigations
Hyperglycemia (High glucose level in blood)
|
9.1%
3/33 • Number of events 4 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Investigations
Hypoalbuminemia (Low level of albumin in blood)
|
12.1%
4/33 • Number of events 8 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Investigations
Hypocalcemia (Low calcium level in blood)
|
9.1%
3/33 • Number of events 5 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Investigations
ypocalcemia (Low calcium level in blood)
|
9.1%
3/33 • Number of events 5 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Investigations
Hypokalemia (Low potassium level in blood)
|
15.2%
5/33 • Number of events 9 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Investigations
Hypomagnesemia (Low magnesium level in blood)
|
9.1%
3/33 • Number of events 4 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Investigations
Hyponatremia (Low sodium level in blood)
|
12.1%
4/33 • Number of events 5 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Nervous system disorders
Anxiety
|
9.1%
3/33 • Number of events 3 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Nervous system disorders
Confusion
|
12.1%
4/33 • Number of events 4 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Nervous system disorders
Dizziness
|
6.1%
2/33 • Number of events 2 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Nervous system disorders
Headache
|
6.1%
2/33 • Number of events 4 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Nervous system disorders
Insomnia
|
21.2%
7/33 • Number of events 7 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
9.1%
3/33 • Number of events 3 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.1%
3/33 • Number of events 5 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
General disorders
Abdominal pain
|
15.2%
5/33 • Number of events 8 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
General disorders
Extremity - Limb pain
|
6.1%
2/33 • Number of events 2 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
General disorders
Neck Pain
|
6.1%
2/33 • Number of events 2 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
2/33 • Number of events 2 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (Shortness of breath)
|
6.1%
2/33 • Number of events 2 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
9.1%
3/33 • Number of events 3 • Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place